Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers (NOVA)
27. april 2026 opdateret af: Jung-min Ahn
The objective of this study is to demonstrate the primary hypothesis that, in patients with chronic and acute coronary syndromes requiring percutaneous coronary intervention (PCI), the novel sirolimus-ascorbic acid eluting stent (D+Storm Novonix) is non-inferior to the standard treatment, the everolimus-eluting stent (Synergy XD), with respect to the incidence of target lesion failure (TLF) at 1 year after treatment, where TLF is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
2034
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jung-hee Ham Project Manager, Registered Nurse
- Telefonnummer: 82-2-3010-4728
- E-mail: cvcrc5@amc.seoul.kr
Studiesteder
-
-
-
Seoul, Sydkorea
- Asan Medical Center
-
Kontakt:
- Jung-min Ahn, MD
- Telefonnummer: 82-2-3010-4728
- E-mail: cvcrc5@amc.seoul.kr
-
Ledende efterforsker:
- Jung-min Ahn, MD, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Adult men and women aged 19 years or older
- Patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require percutaneous coronary intervention (PCI) (all-comers)
- Patients who have voluntarily provided written informed consent to participate in the study
Exclusion Criteria:
- Cardiogenic shock within 48 hours prior to the procedure
- Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)
- Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year
- Women who are pregnant, breastfeeding, or of childbearing potential
- Clinically significant abnormalities identified during study visits, physical examination, laboratory tests, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the safe completion of the study
- Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol
- Patients who are unwilling or unable to comply with the study protocol
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sirolimus-Ascorbic Acid Eluting Stent
D+STORM NOVONIX stent
|
bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent
|
|
Aktiv komparator: Everolimus-Eluting Stent
SYNERGY XD
|
bioabsorbable polymer everolimus-eluting stent
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The event rate of Target Lesion Failure
Tidsramme: 1 year
|
Target Lesion Failure is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.
|
1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The event rate of Device success
Tidsramme: 1 year
|
Acute Success Endpoints_lesion level
|
1 year
|
|
The event rate of Procedural success
Tidsramme: 1 year
|
Acute Success Endpoints_patient level
|
1 year
|
|
The event rate of Death from any causes
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
|
1 year
|
|
The event rate of Any stroke
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
|
1 year
|
|
The event rate of Any myocardial infarction
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
|
1 year
|
|
The event rate of Any repeat revascularization
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
|
1 year
|
|
The event rate of Cardiovascular death
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure
|
1 year
|
|
The event rate of Target vessel myocardial infarction
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure
|
1 year
|
|
The event rate of Target vessel revascularization
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure
|
1 year
|
|
The event rate of All-cause death
Tidsramme: 1 year
|
Individual Clinical Endpoints_Mortality
|
1 year
|
|
The event rate of Cardiac death
Tidsramme: 1 year
|
Individual Clinical Endpoints_Mortality
|
1 year
|
|
The event rate of Non-cardiac death
Tidsramme: 1 year
|
Individual Clinical Endpoints_Mortality
|
1 year
|
|
The event rate of All myocardial infarction including Q wave and Non-Q wave
Tidsramme: 1 year
|
Individual Clinical Endpoints_Myocardial Infarction
|
1 year
|
|
The event rate of Non-target vessel myocardial infarction
Tidsramme: 1 year
|
Individual Clinical Endpoints_Myocardial Infarction
|
1 year
|
|
The event rate of All revascularization
Tidsramme: 1 year
|
Individual Clinical Endpoints_Revascularization
|
1 year
|
|
The event rate of All target lesion revascularization
Tidsramme: 1 year
|
Individual Clinical Endpoints_Revascularization
|
1 year
|
|
The event rate of All target vessel revascularization
Tidsramme: 1 year
|
Individual Clinical Endpoints_Revascularization
|
1 year
|
|
The event rate of Non-target vessel revascularization
Tidsramme: 1 year
|
Individual Clinical Endpoints_Revascularization
|
1 year
|
|
The event rate of Any stroke
Tidsramme: 1 year
|
Individual Clinical Endpoints_Stroke
|
1 year
|
|
The event rate of Ischemic stroke
Tidsramme: 1 year
|
Individual Clinical Endpoints_Stroke
|
1 year
|
|
The event rate of Hemorrhagic stroke
Tidsramme: 1 year
|
Individual Clinical Endpoints_Stroke
|
1 year
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The event rate of Definite or probable stent thrombosis
Tidsramme: 1 year
|
Safety Endpoints
|
1 year
|
|
The event rate of Definite stent thrombosis
Tidsramme: 1 year
|
Safety Endpoints
|
1 year
|
|
The event rate of Probable stent thrombosis
Tidsramme: 1 year
|
Safety Endpoints
|
1 year
|
|
The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5
Tidsramme: 1 year
|
Safety Endpoints
|
1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. juni 2026
Primær færdiggørelse (Anslået)
15. juni 2027
Studieafslutning (Anslået)
15. juni 2028
Datoer for studieregistrering
Først indsendt
27. april 2026
Først indsendt, der opfyldte QC-kriterier
27. april 2026
Først opslået (Faktiske)
4. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AMCCV 2026-02
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